Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization

Completed · Phase 3

Conditions studied: Bacterial Infections

In brief

The main purpose of this study is to determine if the Angiotech central venous catheter (CVC) is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing bacterial catheter colonization. Other objectives of this study are to determine if the Angiotech CVC is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing catheter-related local infection, and catheter-related bloodstream infection. This study will also assess the safety of the Angiotech CVC.

Key facts

Study ID

NCT00288418

Run by

Angiotech Pharmaceuticals

People needed

960

Starts

2005-12-01

Expected to finish

2007-07-01

Last updated by the study team

2013-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• at least 18 years of age
• Be initially hospitalized in an intensive care setting
• Require insertion of a triple-lumen central venous catheter for an anticipated period of up to 28 days
• If female and of child-bearing potential, provide evidence of a negative pregnancy test

You may not qualify if…

• Has a life expectancy of less than one month
• Is pregnant
• Has a history of anaphylactic reactions, including reactions to contrast dyes
• Has a history of allergy to 5-fluorouracil (5-FU) or chlorhexidine

Where it is running

• Cardio-Thoracic Surgeons, P.C. — Birmingham, Alabama, United States
• Pulmonary Consultant Group — Orange, California, United States
• Pulmonary Center Sharp Memorial Hospital — San Diego, California, United States
• Kaiser Permanente Santa Teresa — San Jose, California, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Christiana Care Research Institute — Newark, Delaware, United States
• Florida Research Network, LLC — Gainesville, Florida, United States
• Atlanta Institute for Medical Research Inc — Decatur, Georgia, United States
• Kerry Thibodeaux, M.D. — Opelousas, Louisiana, United States
• UMASS Medical School, Dept of Anesthesiology — Worcester, Massachusetts, United States
• Newark Beth Israel Hospital — Newark, New Jersey, United States
• Pulmonary and Critical Care Medicine — Cincinnati, Ohio, United States
• St Vincent Mercy Medical Center, Bldg 1 — Toledo, Ohio, United States
• Medical University of Ohio — Toledo, Ohio, United States
• Universty of Oklahoma HSC — Oklahoma City, Oklahoma, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Rapid City Regional Hospital — Rapid City, South Dakota, United States
• University of Virginia, Department of Anesthesiology — Charlottesville, Virginia, United States
• Winchester Medical Center — Winchester, Virginia, United States
• Franciscan Health System Research Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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